iCARE 2.0: A Pilot Intervention of Dialectical Behavioural Therapy for Youth With Type 2 Diabetes.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Pediatric Quality of Life (PedsQL)
研究概览
简要总结
In partnership with youth, parents, and community members the investigators have co-developed a program of research designed to address the substantial health disparities faced by First Nations children and families, and the calls to action from the Truth and Reconciliation Report. Specifically; the investigators aim to address the high rates of kidney disease in Indigenous children living with Type 2 Diabetes (T2D), by identifying and understanding the root causes for progression of kidney disease and working together to build an evidenced based, novel therapy for diabetes that focuses on mindfulness, personal strengths and incorporates traditional medicine practices that are meaningful to patients.
The investigators have planned 2 pilots in order to address the uncertainties surrounding the planning of a larger definitive trial and allow adequate engagement and building of a meaningful traditional medicine component. These pilots will inform the development of a co-designed, feasible, and embraced Dialectical Behavioural Therapy (DBT) skills training and traditional teachings intervention, which is adequately powered to examine effectiveness on outcomes such as mental wellness, medication adherence, and improved glycemic control and renal function.
Research Aims: 1. Determine the recruitment, enrollment and adherence rates to the intervention. 2. Evaluate acceptability of the intervention using traditional qualitative methods and Indigenous world view methodology 3. Determine the estimated effect size required to power a large-scale DBT randomized control trial for the outcomes quality of life (primary), glycemic control and albuminuria (secondary).
Study Hypotheses: 1. The investigators hypothesize that a DBT intervention will be feasible on a local and National Platform and will be acceptable and embraced by youth with T2D as an important component of their management plan. 2. The investigators hypothesize that the additional of traditional medicine elements will increase the acceptability and adherence to DBT for Indigenous children.
详细描述
The investigators will conduct a quasi-experimental trial with a small sample of adolescents and one family member to participate in group-based Dialectical Behavioural Therapy (DBT) or be randomized to a control arm. Pre-measures, post-measures, and 3-month follow up measures will be collected on DBT participants and control participants. Participants receiving DBT and parents/guardian of the DBT participants will also be asked to complete 1-on-1 qualitative interviews after the 16-week program is finished. Pilot 1 will consist of group-based DBT and Pilot 2 will consist of group-based DBT with an optional component which incorporates traditional Indigenous medicines and knowledge. Pilot 2 will be built with Indigenous scholars and elders and will be submitted as an amendment to the University of Manitoba Research Ethics Board when appropriate consultation has been completed. We are only requesting approval for Pilot 1 at this time.
Screening, Enrolment and Intervention Assignment: Research assistants will recruit participants from the Diabetes Education Resource for Children and Adolescents, located in the Community Services Building at the Health Science Center in Winnipeg, Manitoba. Participants currently enrolled in the iCARE Cohort, who have consented to be contacted about future studies and who meet eligibility requirements will also be approached to share information about this study. Interested participants will be screened utilizing a number of questionnaires and self-report measures in person (if allowable), via telephone, or on REDCap
Pilot 1 will be completed virtually through Zoom HealthCare.
The main outcome measures for the pilot trials were selected to inform the feasibility and sample size required for a larger RCT on a national scale. These include recruitment rates, retention rates, adherence to the intervention, retention for follow-up measurements, and satisfaction with the intervention. The investigators will also assess youth and parent experiences and perceptions of the intervention using inductive qualitative research upon completion of the 16-week trial.
The proposed intervention is mental health support intervention, therefore it does not include medication therapy or devices. The program is being delivered by trained clinical psychologist/psychology students.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 22 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Thirty (30) youths (ages 14-22 years old) living with youth onset T2D will be recruited to participate in Pilot 1, fifteen (15) youths, and one caregiver, will be randomized to receive DBT and fifteen (15) adolescents will be randomized to a control group.
- •An additional thirty youths (14-22 years old) will be recruited to participate in Pilot 2.
排除标准
- •Diabetes not diagnosed as type 2 diabetes including: type 1 diabetes, genetic diabetes, cystic fibrosis diabetes, diabetes secondary to medication use.
- •Ever cancer
- •Other chronic illness associated with systemic inflammation (ex. Juvenile rheumatoid arthritis, Crohn's disease)
- •Active psychotic disorder
- •Past year suicide attempt or an active plan
- •Self-reported substance/alcohol use disorder in past (1 year)
- •Patient and/or caregiver unable or unwilling to provide voluntary informed assent/consent
- •Currently pregnant (eligible at 3 months post-partum)
- •Exclusion criteria would include significant self-harm behaviour and substance abuse, which would impair affective participation in a DBT group setting based on clinical judgement.
研究组 & 干预措施
Dialectical Behavioural Therapy
Participants randomized to the Dialectical Behavioural Therapy (DBT) skills training intervention will receive a 90-minute DBT skills training session every week for 16 weeks total. The sessions will be facilitated by a health practitioner supervised by a clinical health psychologist with expertise in program development and DBT-adaptations for a variety of populations. Sessions for Pilot 1 will be delivered via Zoom HealthCare and in person if allowable. In-person sessions would be delivered at the Children's Hospital Research Institute of Manitoba. Pilot 2 will be adapted to address any additional needs uncovered through he qualitative assessment of Pilot 1. Traditional medicine components will be developed within the first 2 years of the grant by Indigenous researchers, patient and parent advisors, elders, and community advisory groups. These elements will be offered as an encouraged, yet optional component (additional modules) within the 16-week DBT intervention in Pilot 2.
干预措施: Dialectical Behavioural Therapy (Behavioral)
Control
Participants randomized to the control arm will receive standard medical care and clinical follow-up. Controls will be offered DBT after completion of Pilot 1 and 2. Participation will be optional.
结局指标
主要结局
Pediatric Quality of Life (PedsQL)
时间窗: 1 year per pilot
The Pediatric Quality of Life (PedsQL - Teen/Young Adult) questionnaire will be used to determine the impact Dialectical Behavioural Therapy (DBT) has on pediatric quality of life. Results will also be used to determine the estimated effect size required to power a large-scale DBT randomized control trial. Scores range from 0 (min) to 100 (max) with higher scores indicating better quality of life.
Study Feasibility
时间窗: 1 year per pilot
Determine the recruitment, enrollment, and adherence rates to the intervention.
Study Acceptability
时间窗: 1 year per pilot
Participant semi-structured interviews will be conducted to generate understanding of the patient experience, including elements of the intervention that were most useful, and elements requiring modification informing needed adaptations for future studies.
次要结局
- Albuminuria(1 year per pilot)
- Glycemic Control(1 year pilot)
研究者
Dr. Brandy Wicklow
Principle Investigator
University of Manitoba